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Immunogenicity for investigational biopharmaceutical products -
Start with the goal in mind
 
 
Paul Chamberlain
 
 
 

Join us for breakfast on Thursday 14th March to listen to Paul Chamberlain, Biopharmaceuticals & Immunogenicity Expert and NDA Advisory Board member, speak about anticipating and avoiding issues for biopharmaceutical development.

 
 
 
All biopharmaceutical products are associated with an intrinsic potential to induce immune responses in treated subjects. Regulatory agencies expect sponsors to evaluate and mitigate these risks during product development, applying a strategy that addresses product- and patient-related factors. Overall, understanding and controlling immunogenicity-related risks are attainable objectives, and approvability should not be compromised if these risks are suitably evaluated from the earliest stages of development.
 
 
When: Thursday 14th March 2019, from 09:00, presentations start at 09:30
 
Where: Am Klopferspitz 19a, 82152 Martinsried/Planegg, BioM Seminarraum, Munich, Germany
REGISTER NOW
 
 
Learning aspects:
 
  • How to apply immunogenicity risk assessment at the lead candidate selection stage
  • Minimizing incremental risks associated with manufacturing
  • Understanding what and how to evaluate, at different stages of clinical development
  • Integrated presentation of data to regulatory agencies
 
 
 
The Breakfast seminar will be an open and interactive workshop with the opportunity to ask questions to Paul. Questions can also be sent in advance to ndaseminar@ndareg.com Please specify if you would like to ask them openly during the seminar or prefer to discuss them privately afterwards.
 
Registration: By Tuesday 12th March 2019 to: ndaseminar@ndareg.com
 
Contact: Nathalie Brodale-Breinbauer, +49 (0) 89 3585 4036, or email nathalie.brodale-breinbauer@ndareg.com
 
This is a complimentary Breakfast seminar. If you are unable to attend, please advise us no later than the 12th March.